Study of Clinical Performance of Corneal Topography Measurement Using an Optical Biometer

NCT01861925 | Completed Results

• 1 other identifier: HS-LS900-TOPO-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to quantify in-vivo repeatability of a new corneal topography measurement mode of an optical biometer, and the clinical performance of measurement in comparison to reference devices.

Conditions

Corneal Topography

Outcome Measures

Primary Outcomes (1)

• In-vivo Repeatability of Corneal Topography Measurements With Lenstar LS 900 Topography: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences Between Two Consecutive Measurements

  Corneal topography is a measurement of the shape of the anterior cornea. The shape of a cornea can be fully quantified by providing a map of local power. "Diopter" is the unit of refractive power of a lens. In case of the cornea, the power K \[diopter\] is related to the radius (curvature) R \[mm\] of the best fitting sphere by the relation K=337.5/R. Here, corneal topography measurements are implemented by the Placido method, i.e. by analyzing the reflection image of a ring-shaped illumination. According to International Standards Organization (ISO) 19980-2012, repeatability of corneal topography is assessed on the central cornea: area with diameter d\<=3mm, and middle cornea: 3mm\<d\<=6mm. "power difference (2 rep. meas.)": sample mean and 95% C.I. of differences of spatial mean of corneal power between two consecutive measurements. "power difference 2 std.dev.": sample mean of twice the deviation of local power differences (two consecutive measurements).

  1 day of examination

Secondary Outcomes (1)

• Equivalence of Corneal Topography Measurement Between Lenstar LS 900 Topography and Atlas 9000: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences for One Measurement Per Device.

  1 day of examination

Other Outcomes (3)

• Equivalence of Corneal Topography Measurement Between Lenstar LS 900 Topography and Atlas 9000: Sample Mean of Std. Dev. of Local Corneal Elevation Differences for One Measurement Per Device.

  1 day of examination

• Equivalence of Keratometry Radius Measurement Between Lenstar LS 900 Topography and Lenstar LS 900: Population Mean of Differences of Keratometry Radius Measurement Between Both Devices.

  1 day of examination

• Equivalence of Keratometry Axis Measurement Between Lenstar LS 900 Topography and Lenstar LS 900: Population Mean of Differences of Keratometry Axis Measurement Between Both Devices.

  1 day of examination

Study Arms (3)

Normal eye

Astigmatism smaller than 1.5 diopters

Large regular astigmatism

Astigmatism of \> 1.5 diopters, regular astigmatism.

Large irregular astigmatism

Astigmatism of \> 1.5 diopters, irregular astigmatism.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers recruited at University Hospital

You may qualify if:

• years or older

You may not qualify if:

• No corneal transplants
• No corneal scar(s)
• No acute infections of the eye
• No weak fixation
• No suspected lack of compliance
• No vulnerable population

Sponsors & Collaborators

• Haag-Streit AG: lead
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (1)

University Hospital Inselspital

Bern, 3010, Switzerland

Location

Results Point of Contact

• Title: Dr. Lucio Robledo, Clinical Trials Biometry
• Organization: Haag Streit AG

lucio.robledo@haag-streit.com

+41 31 978 01 11

Study Officials

• Beatrice Frueh, Prof. Fr.

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: May 24, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 5, 2014
• Results First Posted: June 5, 2014

Record last verified: 2014-05

Locations

CH (1)